US20060116774A1 - Prosthetic acetabular cup and method of manufacture - Google Patents
Prosthetic acetabular cup and method of manufacture Download PDFInfo
- Publication number
- US20060116774A1 US20060116774A1 US11/245,645 US24564505A US2006116774A1 US 20060116774 A1 US20060116774 A1 US 20060116774A1 US 24564505 A US24564505 A US 24564505A US 2006116774 A1 US2006116774 A1 US 2006116774A1
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- layer
- set forth
- bearing
- backing layer
- metal
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
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- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/32—Joints for the hip
- A61F2/34—Acetabular cups
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- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/40—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
- A61L27/44—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix
- A61L27/443—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix with carbon fillers
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- A61F2310/00976—Coating or prosthesis-covering structure made of proteins or of polypeptides, e.g. of bone morphogenic proteins BMP or of transforming growth factors TGF
Definitions
- This invention relates to prosthetic acetabular cups and to methods of making them.
- Open pores at the surface of the implant are rooms for bone trabeculae formation and deep interdigitation. This mechanical interlocking is able to provide long term attachment after complete dissolution of the hydroxyapatite coating.
- Composite/plastic materials are not X-ray lucent.
- a prosthetic acetabular cup which has a bearing surface layer made from a composite material such as, for example, PEEK resin having at least 20%-40% short carbon fibers and a backing layer or layers providing a barrier and/or porosity and/or roughness.
- a bearing surface layer made from a composite material such as, for example, PEEK resin having at least 20%-40% short carbon fibers and a backing layer or layers providing a barrier and/or porosity and/or roughness.
- the backing layer is made from metal and is coated with a bioactive material.
- the backing layer could also be made from PEEK resin to produce a barrier between the composite material or the surface layer and the bone cells in which it will be used.
- the acetabular cup outer layer may be made of a bioactive material such as hydroxyapatite with or without bone morphogenic proteins.
- the method of forming the prosthetic bearing surface has as a first step injection molding and bearing layer of PEEK resin having 20%-40% carbon fiber to form an inner bearing surface. Then metal particles are sputtered on to the outer nonbearing surface of the molded bearing to form a porous backing layer and then hydroxyapatite is sputtered on to the metal backing layer to form an outer surface of the prosthetic bearing element. PEEK may be plasma sprayed on the outer surface of the bearing layer prior to applying the metal layer.
- the metal particle size may be varied to form an interconnected porosity which increases towards the outer surface as the layer is built up. The particle size may increase from smaller to larger to form the increasing interconnected porosity.
- a mixture of metal particles and hydroxyapatite particles may be sputtered on to the backing layer to form the interconnected porosity.
- the bearing layer has about 30% short carbon fibers.
- the bearing layer may be preformed and the backing layer or layers may be applied by sputtering and/or chemical or plasma deposition.
- the metal utilized for the backing layer or layers is preferably selected from the group consisting of titanium, titanium alloy, tantalum, niobium or cobalt chrome alloy.
- bioactive material encourages the bone cells apposition and development; rough surface and/or porous surface provides structure for mechanical fixation after dissolution of the bioactive layer; composite material provides elasticity for natural load distribution to the bone, and also provides highly wear resistant bearing surface; and the benefits of the metallic material, when provided, is to provide an opaque marker for X-rays and a proven biological interface for good bone ongrowth/ingrowth.
- the bioactive material can be hydroxyapatite (HAP) and/or bone morphogenic proteins (BMP).
- the invention also includes a method of making an acetabular cup which includes a bearing surface layer made from a composite material including PEEK resin and at least 20 to 40% short carbon fibers, a backing layer or layers to provide a barrier and/or porosity and/or roughness and which is coated with a bioactive material by either forming the inner bearing surface layer and subsequently applying the backing layer to it, or forming the backing layer and applying the inner bear surface layer to it.
- a bearing surface layer made from a composite material including PEEK resin and at least 20 to 40% short carbon fibers
- a backing layer or layers to provide a barrier and/or porosity and/or roughness and which is coated with a bioactive material by either forming the inner bearing surface layer and subsequently applying the backing layer to it, or forming the backing layer and applying the inner bear surface layer to it.
- the backing layer When preforming the bearing surface layer the backing layer can be applied to it by sputtering, plasma spraying and/or vapor deposition. If the backing layer is preformed the inner bearing surface layer can be provided by molding. The backing layer can be arranged to have a porosity which varies from its inner to its outer sides to form an outer porous surface.
- the bioactive material can be applied by sputtering, plasma spraying or chemical deposition such as chemical vapor deposition. Any well known deposition method can be used.
- FIG. 2 shows an alternative embodiment and method of making a cup according to the invention
- FIG. 3 shows a third alternative embodiment and method of making it
- FIG. 4 shows a fourth alternative embodiment and a method of making the same
- FIG. 6 shows a sixth alternative embodiment and a method of making the same
- FIG. 8 shows a eighth alternative embodiment and a method of making the same.
- HAP Hydroxyapatite
- the ensuing structure provides a prosthetic acetabular cup which has an inner bearing layer made from the composite material which has a natural elasticity for natural load distribution to the bone and provides a high wear-resistant bearing surface.
- the backing layer 2 creates a barrier between the composite material and the bone cells and/or provides an appropriately roughness for bone cell attachment and/or provides open porosity for bone cell ingrowth and the bioactive material 3 encourages the bone cells apposition and development.
- the use of a metallic material for the backing layer 2 provides an opaque marker for X-rays.
- FIG. 2 shows a second method and embodiment.
- the bearing surface layer 4 is made in a similar manner to that described with regard to FIG. 1 , that is the composite structure is injection molded.
- a second layer is then formed by sputtering or spraying commercially pure titanium particles with a plasma torch under vacuum to provide a backing layer 5 , the sputtering being indicated by arrows 6 .
- the size of the titanium particles is small and increases in order to form an interconnected porosity which increases over the width of the structure.
- the porous structure 5 is then coating with HAP by deposition in order to ensure a continuous HAP layer indicated by reference numeral 7 (Pore size: 400 ⁇ m nominal, irregular structure.)
- the porosity of the layer 5 assists in providing a structure for mechanical fixation after dissolution of the bioactive layer 7 .
- the bearing layer 12 and layer 13 are made in a similar manner described with regard to FIGS. 1 to 3 .
- the size of the pure titanium particles 13 and the surface roughness is smooth enough to tolerate the formation of a titanium structure 14 which is obtained by a laser sintering process, for example using the process described in U.S. patent application Ser. No. 10,704,270 filed on Nov. 7, 2004 entitled Laser-Produced Porous Surface.
- the resulting porous structure is then coated with HAP by deposition/sputtering in order to ensure a continuous HAP layer 15 .
- the construction creates a modulus gradient from composite to HA and this can provide a better mechanical construction.
- a benefit of this construction and method is that it provides a predetermined type of porosity (size, extent), some fixation fixtures can be deposited, as indicated by reference numeral 16 , and a porosity, density or a combination can be provided can be provided, for example fins or spikes. If barbs are included they can provide additional multidirectional torsional stability.
- FIG. 5 shows a method and construction which utilizes a preformed metal shell which can be used as an insert.
- the shell is indicated by reference numeral 20 and has an inner surface of specified structure, roughness, and retentive features to permit engagement of a plastic composite bearing surface, indicated by reference numeral 21 .
- the metal perform may be made as a graded metal structure by, for example, laser sintering using titanium and having an overall thickness of 2-3 mm.
- the perform comprises an inner surface layer 22 which is porous to retain the plastic composite bearing surface 21 , a dense layer 23 which acts as a barrier layer to stop ingress of the plastic/composite into the metallic structure and an outer layer 24 which is of controlled interconnected porosity and is intended for bone ingrowth. This has a nominal porosity of 400 ⁇ m which is able to sustain the bone ingrowth referred to above.
- the preformed metal insert is made as shown at the upper part of FIG. 5 and the composite material bearing surface layer 21 is subsequently molded to it.
- the outer surface of the metallic structure is then coated with HAP, indicated by reference numeral 25 , by sputtering or chemical deposition.
- the particle size of the porous layer 22 can be 1 mm to allow the composite to infiltrate and to be retained.
- a bearing surface layer 30 is first made from a composite material including PEEK resin and short carbon fibers by injection molding. PEEK particles are then sputtered by a plasma torch to create a barrier backing layer 31 to prevent ingrowth of the bone cells. At the start of the sputtering process the size of the particles is small and increases in order to form a porous structure. The porous structure layer 31 is then coated with hydroxyapatite, as indicated by reference numeral 32 , by any process which will provide a continuous layer.
- a composite bearing surface layer 35 is formed by a similar process to that used in the previous FIGS. 1 to 4 and 7 by injection molding.
- PEEK particles are sputtered by a plasma torch to provide a predetermined roughness in a layer indicated by reference numeral 36 .
- a thin titanium layer 37 is now applied by a plasma torch under vacuum to form a barrier between the PEEK material layer 36 and the bone cells and the porous structure is then coated with a layer of hydroxyapatite, indicated by reference numeral 38 , by any process that will provide a continuous layer.
- the composite material is preferably PEEK reinforced with 30% carbon fibers produced to actual shape by injecting molding.
- the part can also be formed by a combination of molding/extrusion and machining to final shape.
- hydroxyapatite bioactive layer can be enhanced or replaced by a coating with bone morphogenic proteins in any of the examples, or even omitted.
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Priority Applications (1)
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US11/787,563 US20070191962A1 (en) | 2004-10-12 | 2007-04-16 | Prosthetic acetabular cup and method of manufacture |
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GB0422666.8 | 2004-10-12 | ||
GBGB0422666.8A GB0422666D0 (en) | 2004-10-12 | 2004-10-12 | Prosthetic acetabular cups |
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US11/787,563 Continuation US20070191962A1 (en) | 2004-10-12 | 2007-04-16 | Prosthetic acetabular cup and method of manufacture |
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US20060116774A1 true US20060116774A1 (en) | 2006-06-01 |
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US11/245,645 Abandoned US20060116774A1 (en) | 2004-10-12 | 2005-10-07 | Prosthetic acetabular cup and method of manufacture |
US11/787,563 Abandoned US20070191962A1 (en) | 2004-10-12 | 2007-04-16 | Prosthetic acetabular cup and method of manufacture |
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US11/787,563 Abandoned US20070191962A1 (en) | 2004-10-12 | 2007-04-16 | Prosthetic acetabular cup and method of manufacture |
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US (2) | US20060116774A1 (ja) |
EP (1) | EP1647242B1 (ja) |
JP (1) | JP4580322B2 (ja) |
AT (1) | ATE396671T1 (ja) |
AU (1) | AU2005220248A1 (ja) |
CA (1) | CA2523167C (ja) |
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Also Published As
Publication number | Publication date |
---|---|
CA2523167C (en) | 2013-04-16 |
EP1647242A1 (en) | 2006-04-19 |
DE602005007138D1 (de) | 2008-07-10 |
JP4580322B2 (ja) | 2010-11-10 |
AU2005220248A1 (en) | 2006-04-27 |
EP1647242B1 (en) | 2008-05-28 |
ATE396671T1 (de) | 2008-06-15 |
US20070191962A1 (en) | 2007-08-16 |
GB0422666D0 (en) | 2004-11-10 |
CA2523167A1 (en) | 2006-04-12 |
JP2006158953A (ja) | 2006-06-22 |
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